NCT00313391

Brief Summary

The purpose of this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs can be offset by reduction in total medical utilization costs, such as hospitalizations, ER visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic symptoms.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

April 10, 2006

Last Update Submit

September 23, 2014

Conditions

SchizophreniaSchizoaffective Disorder

Interventions

Risperdal ConstaDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • Primary diagnosis of schizophrenia or schizoaffective disorder
  • or more admissions to psychiatric hospital in past year, OR minimum of 2 hospital admissions and at least 2 incarcerations in the previous year
  • Medicaid recipient
  • Patients requiring concomitant non-antipsychotic psychotropic medication (mood stabilizing, antidepressants, anxiolytics)

You may not qualify if:

  • Past or current psychiatric disorder, other than schizophrenia or schizoaffective disorder
  • Drug or alcohol dependence
  • Serious, unstable medical illness or any acute medical condition
  • Pregnant or lactating females
  • Prior Risperdal Consta treatment
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Hospital

Atlanta, Georgia, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dragana Bugarski-Kirola, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

December 1, 2005

Primary Completion

December 1, 2007

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

US(1)